Who is sponsoring NCT04483791?

NCT04483791 is sponsored by Elixir Medical Corporation.

What drugs are being tested in NCT04483791?

Interventions in NCT04483791: DynamX Novolimus Eluting Coronary Bioadaptor System.

What condition does NCT04483791 study?

NCT04483791 studies Coronary Artery Disease.

Is NCT04483791 still recruiting?

NCT04483791 is currently completed. Last updated 17 October 2024.

Are results published for NCT04483791?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-10-17 · How we verify

NCT04483791

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

DynamX Bioadaptor Hong Kong Registry

Completed Phase 4 Results posted Last updated 17 October 2024

What this trial tests

Phase 4 trial testing DynamX Novolimus Eluting Coronary Bioadaptor System in Coronary Artery Disease in 50 participants. Completed in 31 December 2022.

Timeline

30 September 2020

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Elixir Medical Corporation
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	50
Start date	30 September 2020
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	4 locations across China

Drugs / interventions tested

DynamX Novolimus Eluting Coronary Bioadaptor System

Conditions studied

Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Elixir Medical Corporation

Who can join

Adults 18 to 80, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acute Device Success Primary · Immediately after final stent placement (intraprocedure)

Percentage of patients with an attainment of a final result of \< 30% residual stenosis using the DynamX bioadaptor with standard pre-dilatation and post-dilatation (if applicable) catheters

Group	Value	95% CI
DynamX Novolimus Eluting Coronary Bioadaptor System	49

Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR). Primary · 12 Months

the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization

Group	Value	95% CI
DynamX Novolimus Eluting Coronary Bioadaptor System	0

the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization

Group	Value	95% CI
DynamX Novolimus Eluting Coronary Bioadaptor System	0

Number of Participants With Cardiovascular and Non-Cardiovascular Death Secondary · 1 month

cardiac and non-cardiac

Group	Value	95% CI
DynamX Novolimus Eluting Coronary Bioadaptor System	0

Number of Participants With Cardiovascular and Non-Cardiovascular Death Secondary · 6 months

cardiac and non-cardiac

Group	Value	95% CI
DynamX Novolimus Eluting Coronary Bioadaptor System	0

Number of Participants With Cardiovascular and Non-Cardiovascular Death Secondary · 12 months

cardiac and non-cardiac

Group	Value	95% CI
DynamX Novolimus Eluting Coronary Bioadaptor System	0

Number of Participants With Myocardial Infarction Secondary · 1 month

target vessel and non-target vessel

Group	Value	95% CI
DynamX Novolimus Eluting Coronary Bioadaptor System	0

Number of Participants With Myocardial Infarction Secondary · 6 months

target vessel and non-target vessel

Group	Value	95% CI
DynamX Novolimus Eluting Coronary Bioadaptor System	0

Number of Participants With Myocardial Infarction Secondary · 12 months

target vessel and non-target vessel

Group	Value	95% CI
DynamX Novolimus Eluting Coronary Bioadaptor System	0

Number of Participants With Clinically-Indicated Target Lesion Revascularization Secondary · 1 month

clinically-indicated

Group	Value	95% CI
DynamX Novolimus Eluting Coronary Bioadaptor System	0

Number of Participants With Clinically-Indicated Target Lesion Revascularization Secondary · 6 month

clinically-indicated

Group	Value	95% CI
DynamX Novolimus Eluting Coronary Bioadaptor System	0

Number of Participants With Clinically-Indicated Target Lesion Revascularization Secondary · 12 month

clinically-indicated

Group	Value	95% CI
DynamX Novolimus Eluting Coronary Bioadaptor System	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Through 12-months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DynamX Novolimus Eluting Coronary Bioadaptor System

Serious: 30/50 (60%)

Deaths: 0/50

Serious adverse events (11 terms)

Reaction	System	DynamX Novolimus Eluting C…
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—
Arrhythmia requiring treatment	Cardiac disorders	—
Recurrent ischemia/chest pain	Cardiac disorders	—
Procedure Complications	Injury, poisoning and procedural complications	—
Hypertension	Cardiac disorders	—
Hypotension/Syncope	Cardiac disorders	—
Extremity Pain/Injury	General disorders	—
Chest Infection	Infections and infestations	—
Bleeding Complications/Hematoma	General disorders	—
Renal/UT Events	Renal and urinary disorders	—
Heart Failure	Cardiac disorders	—

Other adverse events (5 terms — click to expand)

Reaction	System	DynamX Novolimus Eluting C…
Recurrent Ischemia/Chest Pain	Cardiac disorders	—
Arrhythmia requiring treatment	Cardiac disorders	—
Hypertension	Cardiac disorders	—
Bleeding complications/hematoma	General disorders	—
Other non-cardiac events	General disorders	—

Most-reported serious reactions: Respiratory Failure, Arrhythmia requiring treatment, Recurrent ischemia/chest pain, Procedure Complications, Hypertension, Hypotension/Syncope, Extremity Pain/Injury, Chest Infection.

Data from ClinicalTrials.gov NCT04483791 adverse events section.

Sponsor's own description

Prospective, non-randomized, multicenter registry

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Elixir Medical Corporation trials

Trials by the same sponsor.

NCT05828173 — A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter · NA · completed
NCT04192747 — The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries · NA · active not recruiting
NCT04562805 — Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT) · NA · active not recruiting
NCT04375085 — DESyne X2 Post Market Follow-up Study · NA · terminated
NCT03634020 — DynamX Sirolimus Study Sirolimus Eluting Coronary Bioadaptor System · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04483791 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Elixir Medical Corporation
Last refreshed: 17 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04483791.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04483791

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (11 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Coronary Artery Disease

Other Elixir Medical Corporation trials

Verify against primary sources